FDA.reportPublic FDA data

NA

Primary DI
00643169703247
Brand
NA
Company
MEDTRONIC, INC.
Model
2292
Device description
CABLE 2292 MDT GLBL
Published
2016-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRGProgrammer, pacemaker
LWPImplantable pulse generator, pacemaker (non-CRT)
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRGProgrammer, PacemakerCardiovascular3
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003314

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003314SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169703247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169703247006431697032476431697032470643169703247

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
00802526628900LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-05-14
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KGOSR2025-10-16
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWP2025-06-25
00763000812058NAMEDTRONIC, INC.OSR2025-04-12
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWP2024-11-13
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
00763000181130NAMEDTRONIC, INC.LWP2024-08-30
00763000378356Instrument Command LibraryMEDTRONIC, INC.OSR2024-05-04
00763000842536NAMEDTRONIC, INC.OSR2023-11-11
00763000842536NAMEDTRONIC, INC.KRG2023-11-11
00763000612665MyCareLink™MEDTRONIC, INC.OSR2023-05-13
00763000181185NAMEDTRONIC, INC.OSR2023-01-30
00763000181185NAMEDTRONIC, INC.KRG2023-01-30
05415067040404NAST. JUDE MEDICAL, INC.LWP2023-01-09
05415067040404NAST. JUDE MEDICAL, INC.OSR2023-01-09
04035479176112DataBridge NABIOTRONIK SE & Co. KGKRG2022-12-14
00763000688400CareLink SmartSync™MEDTRONIC, INC.OSR2022-10-28
00763000688479NAMEDTRONIC, INC.OSR2022-10-28
05415067031174Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
05415067031174Merlin™ST. JUDE MEDICAL, INC.OSR2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.OSR2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
00763000181345NAMEDTRONIC, INC.OSR2021-06-12
00763000414023MyCareLink™MEDTRONIC, INC.OSR2021-02-07